CBL-514 for Subcutaneous Fat

Not yet recruiting at 13 trial locations
SW
Overseen ByShannon Wu
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the CBL-514 injection in reducing belly fat. Participants will receive either the CBL-514 injection or a placebo (a harmless, inactive substance) for comparison. It suits individuals who feel they have excess abdominal fat and wish to explore this treatment's potential benefits. Participants should maintain stable habits and be dissatisfied with their current belly fat. This trial offers a chance to try a new treatment while aiding researchers in assessing its effectiveness and safety. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if they are weight reduction drugs, GLP-1 agonists, long-term steroids, immunosuppressive therapies, or medications affecting CYP1A2 enzymes. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that CBL-514 injection is likely to be safe for humans?

Research has shown that patients generally tolerate CBL-514 injections well. Studies have found that this treatment can significantly reduce belly fat while remaining safe. Most side effects are mild, especially compared to other fat-reduction methods. This makes CBL-514 a promising option for those seeking noninvasive fat reduction.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about CBL-514 injections for reducing subcutaneous fat because they offer a novel approach compared to existing options like liposuction or non-invasive procedures such as CoolSculpting. Unlike these traditional methods that either physically remove fat or freeze it, CBL-514 works by targeting the fat cells directly with a unique compound, potentially breaking them down from the inside out. This approach could mean fewer side effects and a more comfortable experience for patients, as it's less invasive. Plus, the treatment is administered in a simple injection form, which could make it more accessible and convenient for patients seeking body contouring solutions.

What evidence suggests that CBL-514 injection might be an effective treatment for reducing abdominal subcutaneous fat?

Research has shown that CBL-514 can help reduce belly fat. In one study, participants experienced about a 25% decrease in fat after treatment. Another report found that 82.6% of patients noticed improvements in the appearance of their abdomen. In this trial, participants will receive either CBL-514 or a placebo treatment. Previous studies demonstrated that CBL-514 treatment led to an average reduction of 312.1 mL of subcutaneous fat compared to a placebo. These findings suggest that CBL-514 could be a promising non-surgical option for reducing fat.14567

Who Is on the Research Team?

AS

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Are You a Good Fit for This Trial?

This trial is for adults (18+) with moderate or severe belly fat who are unhappy with their abdominal appearance. Participants must have a BMI between 18.5 and 30, stable weight, and be generally healthy without serious heart, liver, kidney issues, uncontrolled diabetes, or allergies to the study drugs.

Inclusion Criteria

Participant maintained a stable lifestyle
I am 18 years old or older.
I am able and willing to consent and follow all study procedures.
See 3 more

Exclusion Criteria

Participant who has impeded coagulation or platelet aggregation
I have had procedures in the treatment area that could affect how the study drug is given.
Participant with contraindications to MRI imaging
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 4 treatments of CBL-514 or placebo administered subcutaneously to the abdomen, once every 4 weeks

16 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CBL-514 Injection

Trial Overview

The study compares CBL-514 injections to placebo (saltwater) injections to see if CBL-514 safely reduces belly fat. Participants are randomly assigned to either group and neither they nor the researchers know which treatment they're getting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: CBL-514 injectionExperimental Treatment1 Intervention
Group II: Injectable 0.9% Sodium Chloride solutionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials
11
Recruited
550+

Citations

Efficacy and Safety of CBL-514 Injection in Reducing ...

CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a noninvasive treatment, CBL-514 could be a new, ...

Caliway's Fat Reduction Drug CBL-514 Phase 2 Clinical ...

In the Per-Protocol (PP) population, as many as 82.6% of participants achieved at least 1-grade improvement in the Clinician Reported Abdominal ...

A Study to Evaluate the Efficacy and Safety of CBL-514 ...

A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal ...

A Randomized, Phase IIa Study of CBL-514 Injection ... - PMC

At a dose of 2.0 mg/cm2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, nonsurgical ...

Caliway's CBL-514 Achieved Better Efficacy than ...

- Compared with placebo, an average of 312.1mL of subcutaneous fat was reduced in the treated area after CBL-514 treatment. - 42.9% of participants lost at ...

Efficacy and Safety of CBL-514 Injection in Reducing ...

CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a non-invasive treatment, CBL-514 ...

A Study to Evaluate the Efficacy and Safety of CBL-514 ...

A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for ...